Status:
COMPLETED
The Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
Lead Sponsor:
RDD Pharma Ltd
Conditions:
Fecal Incontinence
Spinal Cord Injury
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on anal resting pressure and fecal incontinence in patients with spinal cord injury. Approximately 17 subjects ...
Eligibility Criteria
Inclusion
- Signed written informed consent.
- Male or female subjects 18 to 55 years of age;
- Spinal Cord Injury that occurred at least 3 months from randomization day and less than 3 years from randomization day.
- At least 4 unwanted/unexpected incontinent events/week
Exclusion
- Known allergy to Oxymetazoline or silicone.
- Pregnancy or lactation.
- Active cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
- Type 1 diabetes mellitus;
- Insulin treated type 2 diabetes mellitus;
- Renal insufficiency.
- Liver insufficiency.
- Malignant disease within 5 years of screening;
- History of rectal surgery.
- History of HIV, hepatitis B, hepatitis C.
- Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion.
- Has used, in the last 1 week, drugs that may affect blood coagulation, such as Aspirin (at a dose above 500 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
- Hypertension (blood pressure over 150/105 mm Hg in screening visit)
- Unable to understand the use instruction, as judged by the investigator.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02299557
Start Date
November 1 2014
End Date
July 1 2015
Last Update
July 28 2015
Active Locations (1)
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1
Semmelweis Egyetem I. sz. Belgyógyászati Klinika
Budapest, Hungary